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- W2771733849 abstract "In regulated bioanalysis, the acceptance of results is batch-wise. When during clinical development derived pharmacokinetic or pharmacodynamic results from different studies will be combined or compared, it is recommendable to monitor the long-term reproducibility of bioanalytical assays. Long-term reproducibility can be evaluated by control charts generated from control samples included in each batch. We present a methodology for the implementation, construction and evaluation of control charts next to the regular batch acceptance of bioanalytical results. Decision rules can be set up for a statistical evaluation of the results. Violation of a decision rule may lead to a root-cause investigation and corrective actions to improve assay robustness. Three examples of control charts, for pharmacokinetic and pharmacodynamic analytes are presented." @default.
- W2771733849 created "2017-12-22" @default.
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- W2771733849 date "2017-12-01" @default.
- W2771733849 modified "2023-09-23" @default.
- W2771733849 title "The application of control charts in regulated bioanalysis for monitoring long-term reproducibility" @default.
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- W2771733849 doi "https://doi.org/10.4155/bio-2017-0163" @default.
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